BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6915094 · Received October 5, 2017

    Report

    Report Number
    3006630150-2017-03385
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013054
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: TCN-10 LOT #: 102815 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 1.

    Description of Event or Problem · 1

    DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES FOUND THAT BOTH DEVICES HAD EPOXY CHIPPED OUT AND DISCOLORATION. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696097 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10 110916 00813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1